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Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ESK-001
Sponsored by
Alumis Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have completed a prior ESK-001 study Men and Women must use highly effective methods of contraception for the entirety of the study Exclusion Criteria: Pregnancy Received a prohibited concomitant medication

Sites / Locations

  • Investigator Site # 1029
  • Investigator Site #1001
  • Investigator Site # 1023
  • Investigator Site #1021
  • Investigator Site #1018
  • Investigator Site #1007
  • Investigator Site #1002
  • Investigator site # 1030
  • Investigator Site #1025
  • Investigator site # 1028
  • Investigator Site # 1013
  • Investigator Site #1035
  • Investigator Site #1043
  • Investigator Site #1005
  • Investigator Site # 1011
  • Investigator Site #1027
  • Investigator SIte#1036
  • Investigator Site #1017
  • Investigator Site #1026
  • Investigator Site #1010
  • Investigator Site #1031
  • Investigator Site # 1037
  • Investigator Site #1033
  • Investigator Site #1019
  • Investigator Site #1022
  • Investigator Site # 1012
  • Investigator Site #1015
  • Investigator Site # 1006
  • Investigator Site # 1041
  • Investigator Site #2001
  • Investigator Site # 2008
  • Investigator Site #2003
  • Investigator Site #2006
  • Investigator Site # 2004
  • Investigator Site # 2007
  • Investigator Site #2005
  • Investigator Site #2009
  • Investigator Site # 2002
  • Investigator Site # 2010

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESK-001 Dose Level 1

ESK-001 Dose Level 2

Arm Description

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of long-term ESK-001 treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Secondary Outcome Measures

To assess the long-term efficacy of ESK-001
Change from baseline in Psoriasis Area and Severity Index (PASI) over time
To assess the change in quality of life (QoL) with long-term ESK-001 administration
Change from baseline in Dermatology Life Quality Index (DLQI) over time
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001

Full Information

First Posted
February 2, 2023
Last Updated
August 9, 2023
Sponsor
Alumis Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05739435
Brief Title
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
Official Title
A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alumis Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
Detailed Description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESK-001 Dose Level 1
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 2
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Intervention Type
Drug
Intervention Name(s)
ESK-001
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of long-term ESK-001 treatment
Description
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
To assess the long-term efficacy of ESK-001
Description
Change from baseline in Psoriasis Area and Severity Index (PASI) over time
Time Frame
Approximately 3 years
Title
To assess the change in quality of life (QoL) with long-term ESK-001 administration
Description
Change from baseline in Dermatology Life Quality Index (DLQI) over time
Time Frame
Approximately 3 years
Title
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
Description
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have completed a prior ESK-001 study Men and Women must use highly effective methods of contraception for the entirety of the study Exclusion Criteria: Pregnancy Received a prohibited concomitant medication
Facility Information:
Facility Name
Investigator Site # 1029
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigator Site #1001
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigator Site # 1023
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Investigator Site #1021
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Investigator Site #1018
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Investigator Site #1007
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Investigator Site #1002
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Investigator site # 1030
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Investigator Site #1025
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Investigator site # 1028
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Investigator Site # 1013
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigator Site #1035
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Investigator Site #1043
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Investigator Site #1005
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Investigator Site # 1011
City
Columbus
State/Province
Indiana
ZIP/Postal Code
47201
Country
United States
Facility Name
Investigator Site #1027
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Investigator SIte#1036
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Investigator Site #1017
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Investigator Site #1026
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Investigator Site #1010
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Investigator Site #1031
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Investigator Site # 1037
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Investigator Site #1033
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Investigator Site #1019
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Investigator Site #1022
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Investigator Site # 1012
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigator Site #1015
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Investigator Site # 1006
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Investigator Site # 1041
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Investigator Site #2001
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Investigator Site # 2008
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Investigator Site #2003
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Investigator Site #2006
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Investigator Site # 2004
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Investigator Site # 2007
City
North Bay
State/Province
Ontario
ZIP/Postal Code
PiB 3Z7
Country
Canada
Facility Name
Investigator Site #2005
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Investigator Site #2009
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Investigator Site # 2002
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Investigator Site # 2010
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

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